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ATP/AMP Challenge in Healthy Non-smokers, Smokers, Patients With Asthma, and Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been withdrawn prior to enrollment.
(no resources available)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00159315
First Posted: September 12, 2005
Last Update Posted: June 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Duska Scientific Co.
Information provided by:
Imperial College London
  Purpose

In this randomised, cross-over, controlled study, a total of 84 subjects will be included: 12 healthy non-smoking volunteers; 12 current smokers; 30 patients with mild steroid-naïve asthma; and 30 patients with mild-moderate COPD.

Each subject will have 1 screening visit (if necessary) and 2 study visits. At visits 2 and 3 the effects of adenosine 5`-triphosphate (ATP) or adenosine 5`-monophosphate (AMP) challenge, given in a random order, will be tested.


Condition Intervention
Asthma COPD Smoking Procedure: Inhalation Challenge with ATP Procedure: Inhalation Challenge with AMP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Adenosine 5`-Triphosphate (ATP) Challenge in Healthy Non-smokers, Current Smokers and Patients With Mild Asthma and Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • PC20 of ATP and AMP
  • Lung function
  • Borg score
  • Impulse oscillometry (IOS)

Enrollment: 0
Study Start Date: October 2002
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy non-smokers (n=12)

    • Normal spirometry
    • Forced expiratory volume in 1 second (FEV1) reversibility of < 15% after inhaled beta2-agonists*
  2. At risk (current smokers) (n=12)*

    • Normal spirometry, chronic symptoms (cough, sputum production)
    • FEV1 reversibility of < 15% after inhaled beta2-agonists* (* = Global Strategy for the Diagnosis, Management, and Prevention of COPD)
  3. Mild steroid-naïve asthma (n=30)

    • FEV1 more than or equal to 80%
  4. Mild-moderate COPD (n=30)

    • FEV1 50-80%

Exclusion Criteria:

  1. Pregnancy, breast-feeding, or planned pregnancy during the study.
  2. Fertile women not using acceptable contraceptive measures, as judged by the investigator
  3. Upper respiratory infection within the last 4 weeks
  4. Subjects who have received research medication within the previous one month
  5. Subjects unable to give informed consent
  6. Any psychiatric condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159315


Locations
United Kingdom
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
Imperial College London
Duska Scientific Co.
Investigators
Principal Investigator: Sergei A Kharitonov, MD, PhD Imperial College London
  More Information

ClinicalTrials.gov Identifier: NCT00159315     History of Changes
Other Study ID Numbers: DHTABPT0336
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: June 4, 2015
Last Verified: August 2008

Keywords provided by Imperial College London:
Healthy Volunteers (smokers)
Healthy Volunteers (Non-smokers)
Asthma Patients
COPD Patients

Additional relevant MeSH terms:
Asthma
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases